A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV
NCT ID: NCT06102174
Last Updated: 2025-12-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
10 participants
INTERVENTIONAL
2024-02-15
2024-09-03
Brief Summary
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This study will help inform the amount of sisunatovir to be used in future studies of sisunatovir in children.
This study is seeking for participants who:
* Are 1 day to less than or equal to 60 months of age
* weigh more than or equal to 2.5 kilograms to less than or equal to 23 kilograms.
* Have been tested to have RSV by medical tests.
* show signs of LRTI.
All participants in the study will receive many amounts of sisunatovir or placebo. Placebo is a pill that does not have any medicine in it.
Up to 7 visits are required for the study. Some of these visits include checking participants health over the phone and/or a visit at home.
The study will compare the experiences of infants and children receiving sisunatovir to identify the amount of sisunatovir to be used in future studies in infants and children.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Placebo
Oral or Nasogastric tube (NG)
Placebo
Placebo
Sisunatovir
Oral or NG tube
Active
Sisunatovir
Interventions
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Placebo
Placebo
Active
Sisunatovir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive RSV diagnostic test, antigen or molecular test
* Evidence of Lower Respiratory Tract Infection (LRTI)
Exclusion Criteria
* Neonates with intrauterine growth restriction
* Expected to receive an antiviral for another viral infection within 10 days of screening
* Suspected or confirmed clinically significant moderate or severe bacterial infection that may interfere with the evaluation of response to the study intervention
* Known to have significant comorbidities that would limit the ability to administer the study intervention or evaluate the safety or clinical response to the study intervention
1 Day
60 Months
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Kaiser Permanente Los Angeles Medical center
Los Angeles, California, United States
Kaiser Permanente
Los Angeles, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
Kojunkai Daido Hospital
Nagoya, Aichi-ken, Japan
Nintenkai Kagoshima Children's Hospital
Hioki, Kagoshima-ken, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Osaka City General Hospital
Osaka, , Japan
Monti Clinical Research Centre
Mdantsane, Eastern Cape, South Africa
University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
Johannesburg, Gauteng, South Africa
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2023-504425-39-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C5241009
Identifier Type: -
Identifier Source: org_study_id